EP0095440B1 - Hip joint prosthesis without collar - Google Patents

Hip joint prosthesis without collar Download PDF

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Publication number
EP0095440B1
EP0095440B1 EP83730051A EP83730051A EP0095440B1 EP 0095440 B1 EP0095440 B1 EP 0095440B1 EP 83730051 A EP83730051 A EP 83730051A EP 83730051 A EP83730051 A EP 83730051A EP 0095440 B1 EP0095440 B1 EP 0095440B1
Authority
EP
European Patent Office
Prior art keywords
shaft
lump
shoulder
region
joint
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP83730051A
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German (de)
French (fr)
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EP0095440A1 (en
Inventor
Hermann Prof. Dr. Med. Ecke
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Mecron Medizinische Produkte GmbH
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Mecron Medizinische Produkte GmbH
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Publication date
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Priority to AT83730051T priority Critical patent/ATE21618T1/en
Publication of EP0095440A1 publication Critical patent/EP0095440A1/en
Application granted granted Critical
Publication of EP0095440B1 publication Critical patent/EP0095440B1/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/367Proximal or metaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/3676Distal or diaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • A61F2002/30785Plurality of holes parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2002/3678Geometrical features
    • A61F2002/368Geometrical features with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft

Definitions

  • the invention relates to a collarless hip joint prosthesis of the type specified in the preamble of claim 1 for cementless anchoring.
  • Collarless prostheses have also become known which have a taper and wedge in the drilled medullary cavity.
  • Such a prosthesis is described, for example, in EP-A 0 027 159.
  • the disadvantage of these prostheses is that the wedge effect caused by the tapering of the prosthesis shaft in the distal part is very large, so that the stress on the bones in the radial direction is considerable under load and there is a risk of crack formation in particular in the case of osteoporotic bone.
  • the invention is based on the object of designing a hip joint prosthesis of the type mentioned at the outset in such a way that force can be applied over an extended area without selective loading on the one hand - but on the other hand excessive radial stresses in the femur area are avoided.
  • the invention is based on the knowledge that the medullary canal in the area of the minor trochanter, into which the additional unilaterally provided elevation of the shaft of the hip prosthesis according to the invention engages, enables force introduction which ensures a firm fit of the prosthesis with limited forces caused by wedge action. At the same time, an anti-rotation lock is guaranteed and thus prevents loosening due to forces directed transversely to the central axis. Stress forces are primarily introduced in an area below the elevation intended for insertion into the minor trochanter, which has an enlarged taper, while the task of the further distal shaft area preferably consists in the transfer of forces directed transversely to the longitudinal axis of the prosthesis. The point of reference for the resulting moments is also the part of the survey that is located in the small trochanter.
  • the enlargement of the cross section in the area of the maximum curvature of the prosthesis is preferably used to accommodate a bore for fixation, since an enlarged material cross section of the shaft is available here.
  • the shaft of the hip joint prosthesis according to the invention preferably consists of a titanium alloy or else of plastic reinforced with carbon fibers.
  • the prosthesis according to the invention thus fundamentally differs, for example, from a prosthesis known from DE-C2059381, in which a bore is provided on an extension of the collar.
  • the approach is on the "back" of the area of relatively strong curvature or the bend. Anchoring in the minor trochanter is excluded.
  • the insertion of the prosthesis is facilitated by the fact that the cross-section of the shaft in the area of the one-sided elevation is adapted to the cross-section just below the end used to hold the joint ball due to the physiological design.
  • the rounded cross section is flattened on both sides in this area, is ovoid, elliptical or oval.
  • the insertion can easily be achieved by first turning the shaft end by an angle of approximately 90 ° until the area of the one-sided elevation has passed the outer bone opening.
  • the shaft is turned back accordingly, so that the shaft area with the largest cross section at the end near the joint ball fits into the opening, the shoulder being supported in the area of the trochanter minor. This ensures a secure fit of the prosthesis.
  • the shaft can be made relatively short in the case of an anatomical design as a left or right prosthesis, no problems arise when inserting it, and the guiding into the appropriate angular position takes place “of its own accord”, since further insertion is only possible in the correct angular position .
  • the prosthesis additionally has a slight curvature in a plane perpendicular to the plane of greater curvature - as is known from DE-A 2 851 598, the center or centers of the radii of curvature being opposite one another on the one-sided elevation arranged side of the shaft.
  • the prosthesis shaft 2 inserted into the medullary canal of the femur 1 has a curve in its maximum curvature plane (the plane of the illustration according to FIG. 2 is the LM plane) in which the curvature decreases from the proximal to the distal end.
  • the proximal end carries an extension 3, which serves to receive a joint ball 4 (shown in broken lines).
  • the cross section of the prosthesis shaft is essentially rounded over its entire length, the proximal end just below the attachment 3 having a contour as shown in FIG. 3.
  • This contour can be addressed as oval or elliptical.
  • This cross-section decreases continuously towards its distal end, the flattened cross-sectional shape being essentially retained, apart from the one-sided elevation to be described below.
  • the cross-sectional axis with smaller dimensions is perpendicular to the LM plane, in which the main curvature of the prosthesis socket runs.
  • the shaft has a further curvature with a larger radius, the center of which is essentially perpendicular to the plane in which the larger curvature runs - it serves to adapt to the special conditions of the left and right femur .
  • the prosthesis can consist of body-compatible metal alloys as well as corresponding carbon fiber reinforced plastics, the choice of material being made in such a way that sufficient strength is ensured.
  • the prosthesis according to the invention is provided with a one-sided elevation in the form of a shoulder 5, which follows the minor trochanter in its contour.
  • the contour runs in such a way that a corresponding boundary line extends from an area which forms a small angle with the central axis - corresponding to the normal taper - to the top of the elevation 5 into one Range passes over, which forms an enlarged angle with the central axis, the transition taking place continuously.
  • This line forms the left outer boundary in FIG. 1 and runs essentially concave to the apex of the elevation 5 in the region of the bore 6.
  • the shoulder 5 has a comb-like summit region in the region of its highest elevation, which extends in the circumferential direction. From the hinge end of the shaft, the shoulder-shaped elevation follows the cross-section with sharper rounded corner areas with enclosed, essentially flat surface parts according to FIG. 3, while the area adjoining the crest downwards - starting from that shown in FIG. 4 in the area of the bore 6 Profile - approaching an even fillet towards the end.
  • the area of the reinforced material cross section of the shoulder 5 serves to receive a threaded bore 6 with which the shaft can be fixed in the selected position by means of a screw. This fixation forms an additional safeguard, since the shape of the prosthesis filling the minor trochanter ensures its stable fit.
  • the bore 6 runs in the plane of the bend or curvature and is directed essentially perpendicular to the central axis of the shaft.
  • the area corresponding to the cross section shown in FIG. 4 intersects the shoulder 5 in the area of its highest elevation. Without this shoulder, the shaft curved near the joint (curvation) would continuously taper towards its other end. It would always have a greater extension in the plane of this curvature than perpendicular to it.
  • the shoulder-shaped elevation is added to this basic structure and protrudes from the plane of the curvature, the (additional) pitch being less in the longitudinal direction of the shaft than in the circumferential direction.
  • the shoulder thus forms an additional bulge of the prosthesis socket, which otherwise has an essentially even contour.
  • the shoulder protrudes laterally in an area of the shaft which is arranged essentially in the middle of the inner curve of the more curved area.
  • the section according to FIG. 4 goes through the summit area (ridge line) of the elevation designed as shoulder 5.
  • the (additional) shoulder increases the cross-section of the tapered shaft on one side in such a way that the direction of the greatest cross-sectional extension no longer runs here in the plane of curvature, but in a 90 ° direction to it (in FIG. 4, therefore, horizontally instead of vertically) 4 is already rotated by 90 ° with respect to FIG. 3). If the cross-section of the shaft according to FIG. 4 is to pass through the upper opening prepared for the prosthesis cross-section according to FIG. 3, the shaft must be rotated by 90 ° when inserting the area according to FIG to be able to take.
  • the shoulder During this turning to the normal position, the shoulder enters an extension of the external bone structure consisting of corticalis, which is referred to as the "trochanter minor".
  • the shoulder literally looks like a peg corresponding to a one-sided bayonet catch.
  • the dimensions of the shaft are adapted to the dimensions of the human femur.
  • a corresponding threaded hole is also provided in the region of the distal shaft end, which is indicated by the dashed hole 6 '.
  • This hole runs in the lateral-medial direction, since this direction can be easily reached by the aiming device used during the implantation.
  • the corresponding fixation screws cross the femur completely and are used for additional fixation of the shaft.
  • the prosthesis shown in FIGS. 1 to 4 is intended for use on the left. Because of the already asymmetrical and therefore different design for the left and right in the area of the trochanter minor, the curvature with a large radius shown in FIG. 1 and running in the AP plane with a large radius can also be adapted to the anatomical requirements in the left or right femur, so that an optimal fit is guaranteed.
  • the area of maximum force application in the prosthesis according to the invention lies in the surface area which widens from the distal end to the unilateral shoulder 5.
  • the resulting wedge angle is dimensioned so that the radially directed forces are limited.
  • the seat of the prosthesis and thus the introduction of vertical loading forces is distributed over such a large area that micro-movements causing bone resorption are excluded.
  • the medullary opening need not be subjected to complicated shaping in a complex manner, since the prosthesis according to the invention makes use of the physiological conditions found.
  • the length of the prosthesis neck can - depending on the individual requirements - be varied during manufacture.

Description

Die Erfindung betrifft eine kragenlose Hüftgelenkprothese der im Oberbegriff des Anspruchs 1 angegebenen Art zur zementlosen Verankerung.The invention relates to a collarless hip joint prosthesis of the type specified in the preamble of claim 1 for cementless anchoring.

Da sich in der Vergangenheit bei der Verwendung von Knochenzement gewisse Nachteile, wie z.B. Lockerungen, gezeigt haben, ist man bemüht, Endoprothesen möglichst ohne Verwendung von Knochenzement zu befestigen. Dabei treten jedoch ebenfalls eine Reihe von Schwierigkeiten auf. Wenn nämlich beispielsweise der Femurteil, welcher zur Aufnahme des Gelenkkopfes dient, einen «Kragen» aufweist, findet die Krafteinleitung in den Knochen ausschliesslich im Bereich des «überkragenden» Teiles statt. Da aber unter Belastung die bei diesen Verhältnissen in einem eng begrenzten Bereich auftretenden Kräfte relativ gross sind, kann es aufgrund der resultierenden «Wackelbewegungen» zur Lockerung des Prothesenschaftes kommen.Since there have been certain disadvantages in the past when using bone cement, e.g. Loosening, have shown, efforts are made to attach endoprostheses without using bone cement if possible. However, there are also a number of difficulties. If, for example, the femoral part, which is used to hold the joint head, has a “collar”, the force is applied to the bones exclusively in the area of the “projecting” part. However, since the forces occurring in these conditions in a narrowly limited range are relatively large under load, the resulting “wobbling movements” can lead to loosening of the prosthesis socket.

Weiterhin sind kragenlose Prothesen bekannt geworden, welche eine Verjüngung besitzen und sich im ausgebohrten Markraum des Femurs verkeilen. Eine derartige Prothese ist beispielsweise in der EP-A 0 027 159 beschrieben. Bei diesen Prothesen besteht der Nachteil, dass die durch die Verjüngung des Prothesenschaftes im distalen Teil bedingte Keilwirkung sehr gross ist, so dass die Knochenbeanspruchung in radialer Richtung unter Last erheblich ist und insbesondere beim osteoporotischen Knochen die Gefahr der Rissbildung besteht.Collarless prostheses have also become known which have a taper and wedge in the drilled medullary cavity. Such a prosthesis is described, for example, in EP-A 0 027 159. The disadvantage of these prostheses is that the wedge effect caused by the tapering of the prosthesis shaft in the distal part is very large, so that the stress on the bones in the radial direction is considerable under load and there is a risk of crack formation in particular in the case of osteoporotic bone.

Wegen des komplizierten Verlaufs der sich aufweitenden Bereiche im äussersten proximalen Bereich des Schaftes ist es bei genauer Masshaltigkeit und normalen anatomischen Verhältnissen nur sehr schwer möglich, die Anpassung an den Markraum so zu gestalten, dass sich beim Einbringen des Schaftes eine definierte Kraftverteilung einstellt. Wenn die Prothese ausschliesslich in diesem Bereich trägt, kommt es wiederum zu einer mehr oder weniger punktuellen Belastung und den entsprechenden nachteiligen Eigenschaften für die Knochensubstanz.Because of the complicated course of the widening areas in the outermost proximal area of the shaft, it is very difficult, with exact dimensional accuracy and normal anatomical conditions, to adapt to the medullary cavity in such a way that a defined distribution of force occurs when the shaft is inserted. If the prosthesis only wears in this area, there is in turn more or less selective loading and the corresponding disadvantageous properties for the bone substance.

Aus der EP-A 0 044 915 ist ein Schaftteil einer kragenlosen Hüftendoprothese bekanntgeworden, welcher einen eliptischen Querschnitt aufweist, wobei die Verkeilung im Bereich der dem Adambogen folgenden Abbiegung oder Krümmung des Prothesenschaftes erfolgt, so dass bei Belastung der Prothese vergleichsweise kleine Biegemomente wirksam werden und eine übermässige Beanspruchung des Knochengewebes ausgeschlossen sein soll. Auch bei dieser Prothese besteht aber der Nachteil, dass die Anpassung des Markraums an die relativ komplizierte Formgestaltung nur schwer durchführbar ist. Im übrigen muss die Knochenöffnung grossflächig ausgebildet sein, damit die Prothese einsetzbar ist, weil insbesondere der Bereich starker Krümmung mit elliptischem Querschnitt eine grössere Öffnung erfordert, als es dem der Gelenkkugel nahen Endquerschnitt der Prothese entspricht.From EP-A 0 044 915 a shaft part of a collarless hip endoprosthesis has become known which has an elliptical cross-section, the wedging taking place in the region of the bend or curvature of the prosthesis shaft following the adam arch, so that comparatively small bending moments become effective when the prosthesis is loaded excessive stress on the bone tissue should be excluded. However, this prosthesis also has the disadvantage that it is difficult to adapt the medullary canal to the relatively complicated shape. In addition, the bone opening must have a large area so that the prosthesis can be used, because in particular the area of strong curvature with an elliptical cross section requires a larger opening than corresponds to the end cross section of the prosthesis close to the joint ball.

Weiterhin ist aus der DE-A 2851 598 eine Prothese der eingangs genannten Gattung bekannt, bei der der Schaft in der AP-Ebene eine s-förmige Biegung aufweist. Diese Biegung bildet eine Anpassung an den natürlichen Verlauf des Markkanals in verhältnismässig grossem Abstand vom Hals und kann deshalb nur auf Prothesen mit relativ grosser Länge des Schafts angewendet werden. Da dem konvexen Bereich ein entsprechender konkaver Bereich auf der gegenüberliegenden Schaftseite entspricht, tritt eine feste Verklemmung nicht ein. Ein ausschliesslich s-förmig gebogenes Gebilde ist zur Erzielung eines Klemmsitzes nicht sehr geeignet.Furthermore, from DE-A 2851 598 a prosthesis of the type mentioned at the outset is known, in which the shaft has an S-shaped bend in the AP plane. This bend forms an adaptation to the natural course of the medullary canal at a relatively large distance from the neck and can therefore only be used on prostheses with a relatively large length of the shaft. Since the convex area corresponds to a corresponding concave area on the opposite side of the shaft, a firm jamming does not occur. An exclusively S-shaped structure is not very suitable for achieving a press fit.

Der Erfindung liegt die Aufgabe zugrunde, eine Hüftgelenkprothese der eingangs genannten Art derart auszubilden, dass einerseits die Krafteinleitung über einen ausgedehnten Bereich ohne punktuelle Belastung erfolgen kann - andererseits aber zu grosse radiale Spannungen im Femurbereich vermieden sind.The invention is based on the object of designing a hip joint prosthesis of the type mentioned at the outset in such a way that force can be applied over an extended area without selective loading on the one hand - but on the other hand excessive radial stresses in the femur area are avoided.

Diese Aufgabe ist durch eine Hüftgelenkprothese mit den im kennzeichnenden Teil des Anspruchs 1 angegebenen Merkmalen gelöst.This object is achieved by a hip joint prosthesis with the features specified in the characterizing part of claim 1.

Die Erfindung beruht auf der Erkenntnis, dass der Markkanal im Bereich des Trochanter minor, in den die zusätzliche einseitig vorgesehene Erhebung des Schafts der erfindungsgemässen Hüftgelenkprothese eingreift, eine Krafteinleitung ermöglicht, die einen festen Sitz der Prothese bei begrenzten durch Keilwirkung verursachten Kräften sicherstellt. Gleichzeitig ist eine Drehsicherung gewährleistet und damit eine Auslockerung infolge von quer zur Mittelachse gerichteten Kräften verhindert. Die Einleitung von Belastungskräften erfolgt vorwiegend in einem Bereich unterhalb der zum Einlassen in den Trochanter minor bestimmten Erhebung, der eine vergrösserte Verjüngung aufweist, während die Aufgabe des weiteren distalen Schaftbereichs bevorzugt in der Überleitung von quer zur Prothesenlängsachse gerichteten Kräften besteht. Bezugspunkt für die sich hierbei ergebenden Momente ist ebenfalls derjenige Teil der Erhebung, welcher im kleinen Trochanter Platz findet.The invention is based on the knowledge that the medullary canal in the area of the minor trochanter, into which the additional unilaterally provided elevation of the shaft of the hip prosthesis according to the invention engages, enables force introduction which ensures a firm fit of the prosthesis with limited forces caused by wedge action. At the same time, an anti-rotation lock is guaranteed and thus prevents loosening due to forces directed transversely to the central axis. Stress forces are primarily introduced in an area below the elevation intended for insertion into the minor trochanter, which has an enlarged taper, while the task of the further distal shaft area preferably consists in the transfer of forces directed transversely to the longitudinal axis of the prosthesis. The point of reference for the resulting moments is also the part of the survey that is located in the small trochanter.

Die Vergrösserung des Querschnitts im Bereich der maximalen Krümmung der Prothese dient bevorzugt zur Aufnahme einer Bohrung zur Fixierung, da hier ein vergrösserter Materialquerschnitt des Schaftes zur Verfügung steht. Zusätzlich befindet sich im Bereich des distalen Endes eine Gewindebohrung zur Fixation. Der Schaft der erfindungsgemässen Hüftgelenkprothese besteht vorzugsweise aus einer Titanlegierung oder aber aus mit Kohlenstoffasern verstärktem Kunststoff.The enlargement of the cross section in the area of the maximum curvature of the prosthesis is preferably used to accommodate a bore for fixation, since an enlarged material cross section of the shaft is available here. In addition, there is a threaded hole for fixation in the area of the distal end. The shaft of the hip joint prosthesis according to the invention preferably consists of a titanium alloy or else of plastic reinforced with carbon fibers.

Die erfindungsgemässe Prothese unterscheidet sich damit grundsätzlich auch beispielsweise von einer aus der DE-C2059381 bekannten Prothese, bei der eine Bohrung an einem Ansatz des Kragens vorgesehen ist. Hier befindet sich der Ansatz auf dem «Rücken» des Bereichs verhältnismässig starker Krümmung oder der Abbiegung. Eine Verankerung im Trochanter minor ist ausgeschlossen.The prosthesis according to the invention thus fundamentally differs, for example, from a prosthesis known from DE-C2059381, in which a bore is provided on an extension of the collar. Here the approach is on the "back" of the area of relatively strong curvature or the bend. Anchoring in the minor trochanter is excluded.

Das Einsetzen der Prothese ist dadurch erleichtert, dass der Querschnitt des Schaftes im Bereich der einseitigen Erhebung durch die physiologische Gestaltung dem Querschnitt kurz unterhalb des zur Aufnahme der Gelenkkugel dienenden Endes angepasst ist. Der abgerundete Querschnitt ist in diesem Bereich beidseitig abgeflacht, ovoid, ellipsenförmig oder oval ausgebildet.The insertion of the prosthesis is facilitated by the fact that the cross-section of the shaft in the area of the one-sided elevation is adapted to the cross-section just below the end used to hold the joint ball due to the physiological design. The rounded cross section is flattened on both sides in this area, is ovoid, elliptical or oval.

Das Einsetzen lässt sich bei einer entsprechenden Gestaltung der Öffnung im proximalen Knochenende ohne weiteres dadurch erreichen, dass das Schaftende beim Einsetzen zunächst um einen Winkel von etwa 90° verdreht geführt wird, bis der Bereich der einseitigen Erhebung die äussere Knochenöffnung passiert hat. Mit dem Erreichen des Bereichs des Trochanter minor im Markkanal wird der Schaft entsprechend zurückgedreht, so dass der Schaftbereich mit grösstem Querschnitt an dem der Gelenkkugel nahen Ende sich in die Öffnung einfügt, wobei sich die Schulter im Bereich des Trochanter minor abstützt. Dadurch ist ein sicherer Sitz der Prothese gewährleistet. Da der Schaft bei anatomischer Gestaltung als Links- oder Rechtsprothese verhältnismässig kurz ausgebildet sein kann, treten beim Einbringen keine Probleme auf, und die Führung in die geeignete Winkelposition erfolgt gleichsam «von selbst», da nur in der jeweils korrekten Winkelposition ein weiteres Einführen ermöglicht ist.With an appropriate design of the opening in the proximal end of the bone, the insertion can easily be achieved by first turning the shaft end by an angle of approximately 90 ° until the area of the one-sided elevation has passed the outer bone opening. When the area of the trochanter minor in the medullary canal is reached, the shaft is turned back accordingly, so that the shaft area with the largest cross section at the end near the joint ball fits into the opening, the shoulder being supported in the area of the trochanter minor. This ensures a secure fit of the prosthesis. Since the shaft can be made relatively short in the case of an anatomical design as a left or right prosthesis, no problems arise when inserting it, and the guiding into the appropriate angular position takes place “of its own accord”, since further insertion is only possible in the correct angular position .

Gemäss bevorzugten Weiterbildungen der Erfindung weist die Prothese zusätzlich eine geringe Krümmung in einer zu der Ebene grösserer Krümmung senkrechten Ebene auf - wie es aus der DE-A 2 851 598 bekannt ist, wobei der oder die Mittelpunkte der Krümmungsradien sich auf der der einseitigen Erhebung gegenüber angeordneten Seite des Schaftes befinden.According to preferred developments of the invention, the prosthesis additionally has a slight curvature in a plane perpendicular to the plane of greater curvature - as is known from DE-A 2 851 598, the center or centers of the radii of curvature being opposite one another on the one-sided elevation arranged side of the shaft.

Andere vorteilhafte Weiterbildungen sind in den abhängigen Ansprüchen angegeben. Ein Ausführungsbeispiel der Erfindung wird nachfolgend näher beschrieben. Es zeigen:

  • Fig. 1 die erfindungsgemässe Prothese von der Körperachse her gesehen, in der AP-Ebene dargestellt.
  • Fig. 2 dieselbe Prothese von posterior her betrachtet (Zeichenebene ist die LM-Ebene) und
  • Fig. 3 und 4 Querschnitte durch die erfindungsgemässe Prothese in zwei verschiedenen Schnittebenen gemäss Figur 2, wobei Figur 3 in bezug auf Figur 4 um 90° versetzt dargestellt ist. Die Zeichnung ist etwa im Massstab 1:1 gehalten.
Other advantageous developments are specified in the dependent claims. An embodiment of the invention is described in more detail below. Show it:
  • Fig. 1 seen the prosthesis according to the invention from the body axis, shown in the AP plane.
  • Fig. 2 the same prosthesis viewed from the posterior (drawing level is the LM level) and
  • 3 and 4 cross sections through the prosthesis according to the invention in two different sectional planes according to Figure 2, wherein Figure 3 is shown offset by 90 ° with respect to Figure 4. The drawing is kept on a scale of 1: 1.

Der in den Markkanal des Femurs 1 eingesetzte Prothesenschaft 2 weist in seiner Ebene maximaler Krümmung (Darstellungsebene gemäss Figur 2 ist die LM-Ebene) einen Verlauf auf, bei dem die Krümmung vom proximalen zum distalen Ende hin abnimmt. Das proximale Ende trägt einen Ansatz 3, welcher zur Aufnahme einer (gestrichelt dargestellten) Gelenkkugel 4 dient.The prosthesis shaft 2 inserted into the medullary canal of the femur 1 has a curve in its maximum curvature plane (the plane of the illustration according to FIG. 2 is the LM plane) in which the curvature decreases from the proximal to the distal end. The proximal end carries an extension 3, which serves to receive a joint ball 4 (shown in broken lines).

Der Querschnitt des Prothesenschafts ist über seine gesamte Länge im wesentlichen gerundet, wobei das proximale Ende kurz unterhalb des Ansatzes 3 eine Kontur aufweist, wie sie in Figur 3 dargestellt ist.The cross section of the prosthesis shaft is essentially rounded over its entire length, the proximal end just below the attachment 3 having a contour as shown in FIG. 3.

Diese Kontur ist als oval oder ellipsenförmig anzusprechen. Zu seinem distalen Ende hin verringert sich dieser Querschnitt kontinuierlich, wobei - abgesehen von der noch zu beschreibenden einseitigen Erhebung - die abgeflachte Querschnittform im wesentlichen beibehalten wird. Die Querschnittsachse mit kleinerer Abmessung steht dabei senkrecht zurLM-Ebene, in der auch die Hauptkrümmung des Prothesenschaftes verläuft.This contour can be addressed as oval or elliptical. This cross-section decreases continuously towards its distal end, the flattened cross-sectional shape being essentially retained, apart from the one-sided elevation to be described below. The cross-sectional axis with smaller dimensions is perpendicular to the LM plane, in which the main curvature of the prosthesis socket runs.

Wie aus Figur 1 ersichtlich ist, weist der Schaft noch eine weitere Krümmung mit grösserem Radius auf, deren Mittelpunkt sich im wesentlichen senkrecht über der Ebene befindet, in dem die grössere Krümmung verläuft - sie dient zur Anpassung an die besonderen Gegebenheiten des linken und rechten Femur.As can be seen from FIG. 1, the shaft has a further curvature with a larger radius, the center of which is essentially perpendicular to the plane in which the larger curvature runs - it serves to adapt to the special conditions of the left and right femur .

Die Prothese kann sowohl aus körperverträglichen Metallegierungen als auch aus entsprechenden kohlenstoffaserverstärkten Kunststoffen bestehen, wobei die Werkstoffauswahl derart erfolgt, dass eine ausreichende Festigkeit gewährleistet ist.The prosthesis can consist of body-compatible metal alloys as well as corresponding carbon fiber reinforced plastics, the choice of material being made in such a way that sufficient strength is ensured.

Die erfindungsgemässe Prothese ist mit einer einseitigen Erhebung in Form einer Schulter 5 versehen, welche in ihrer Kontur dem Trochanter minor folgt. In Längsrichtung des Schaftes 2 auf der Oberfläche über den Bereich der Schulter verläuft die Kontur dabei derart, dass eine entsprechende Begrenzungslinie von einem Bereich, der mit der Mittelachse einen kleinen Winkel - entsprechend der normalen Verjüngung - bildet, zum Gipfel der Erhebung 5 hin in einen Bereich übergeht, der mit der Mittelachse einen vergrösserten Winkel bildet, wobei der Übergang kontinuierlich erfolgt. Diese Linie bildet die linke äussere Begrenzung in Figur 1 und verläuft zum Scheitelpunkt der Erhebung 5 im Bereich der Bohrung 6 im wesentlichen konkav. Die Schulter 5 weist im Bereich ihrer höchsten Erhebung einen kammartigen Gipfelbereich auf, der sich in Umfangsrichtung erstreckt. Vom Gelenkende des Schaftes her folgt die schulterförmige Erhebung eher dem Querschnitt mit schärfer verrundeten Eckbereichen mit eingeschlossenen, im wesentlichen ebenen Flächenteilen gemäss Figur 3, während der nach unten an den Kamm anschliessende Bereich sich - ausgehend von dem in Figur 4 im Bereich der Bohrung 6 dargestellten Profil - zum Ende hin einer gleichmässigen Verrundung nähert.The prosthesis according to the invention is provided with a one-sided elevation in the form of a shoulder 5, which follows the minor trochanter in its contour. In the longitudinal direction of the shaft 2 on the surface over the area of the shoulder, the contour runs in such a way that a corresponding boundary line extends from an area which forms a small angle with the central axis - corresponding to the normal taper - to the top of the elevation 5 into one Range passes over, which forms an enlarged angle with the central axis, the transition taking place continuously. This line forms the left outer boundary in FIG. 1 and runs essentially concave to the apex of the elevation 5 in the region of the bore 6. The shoulder 5 has a comb-like summit region in the region of its highest elevation, which extends in the circumferential direction. From the hinge end of the shaft, the shoulder-shaped elevation follows the cross-section with sharper rounded corner areas with enclosed, essentially flat surface parts according to FIG. 3, while the area adjoining the crest downwards - starting from that shown in FIG. 4 in the area of the bore 6 Profile - approaching an even fillet towards the end.

Der Querschnitt in diesem Bereich ist in Figur 4 dargestellt, wobei ersichtlich ist, dass eine Annäherung an die Kontur des Querschnitts im Bereich der Linie 111-111 in Figur 2 gegeben ist, so dass dieser Querschnittsbereich gemäss Figur 4 ohne Schwierigkeiten eine Öffnung passieren kann, welche den Querschnitt gemäss Figur 3 durchlässt. Es ist dabei lediglich eine Drehung um die Längsachse um einen vorgegebenen Winkel von im wesentlichen 90° notwendig. Da die Kontur des Schaftes gerundet ohne Stufen ausgebildet ist, ergibt sich eine nahezu selbsttätige Führung beim Einbringen in den Markraum.The cross-section in this area is shown in FIG. 4, it being evident that there is an approximation to the contour of the cross-section in the area of line 111-111 in FIG. 2, so that this cross-sectional area according to FIG. 4 can pass through an opening without difficulty, which allows the cross section according to Figure 3. All that is required is a rotation about the longitudinal axis through a predetermined angle of essentially 90 °. Since the contour of the shaft is rounded without steps, there is an almost automatic guidance when inserting it into the medullary canal.

Der Bereich des verstärkten Materialquerschnitts der Schulter 5 dient zur Aufnahme einer Gewindebohrung 6, mit der der Schaft durch eine Schraube in der gewählten Position fixierbar ist. Diese Fixierung bildet eine zusätzliche Sicherung, da durch die den Trochanter minor ausfüllende Formung der Prothese deren stabiler Sitz sichergestellt ist. Die Bohrung 6 verläuft dabei in der Ebene der Abbiegung oder Krümmung und ist im wesentlichen senkrecht zur Mittelachse des Schafts gerichtet.The area of the reinforced material cross section of the shoulder 5 serves to receive a threaded bore 6 with which the shaft can be fixed in the selected position by means of a screw. This fixation forms an additional safeguard, since the shape of the prosthesis filling the minor trochanter ensures its stable fit. The bore 6 runs in the plane of the bend or curvature and is directed essentially perpendicular to the central axis of the shaft.

Der Bereich, wie er dem in Figur 4 wiedergegebenen Querschnitt entspricht, schneidet die Schulter 5 im Bereich ihrer höchsten Erhebung. Ohne diese Schulter würde der im gelenknahen Bereich gekrümmte (Curvation) Schaft sich zu seinem anderen Ende hin stetig verjüngen. Er würde in der Ebene dieser Krümmung stets eine grössere Erstreckung haben als senkrecht dazu. Die schulterförmige Erhebung ist dieser Grundstruktur hinzugefügt und ragt aus der Ebene der Krümmung heraus, wobei in Längsrichtung des Schaftes die (zusätzliche) Steigung geringer ist als in Umfangsrichtung. Die Schulter bildet also eine zusätzliche Ausbauchung des sonst im wesentlichen eine ebenmässige Kontur aufweisenden Prothesenschaftes. Die Schulter ragt in einem Bereich des Schaftes seitlich hervor, der im wesentlichen in der Mitte der Innenkurve des stärker gekrümmten Bereichs angeordnet ist.The area corresponding to the cross section shown in FIG. 4 intersects the shoulder 5 in the area of its highest elevation. Without this shoulder, the shaft curved near the joint (curvation) would continuously taper towards its other end. It would always have a greater extension in the plane of this curvature than perpendicular to it. The shoulder-shaped elevation is added to this basic structure and protrudes from the plane of the curvature, the (additional) pitch being less in the longitudinal direction of the shaft than in the circumferential direction. The shoulder thus forms an additional bulge of the prosthesis socket, which otherwise has an essentially even contour. The shoulder protrudes laterally in an area of the shaft which is arranged essentially in the middle of the inner curve of the more curved area.

Der Schnitt gemäss Figur 4 geht durch den Gipfelbereich (Kammlinie) der als Schulter 5 ausgebildeten Erhebung. Durch die (zusätzliche) Schulter wird der Querschnitt des verjüngten Schafts einseitig in der Weise vergrössert, dass die Richtung der grössten Querschnittserstrekkung hier nicht mehr in der Krümmungsebene verläuft, sondern in einer 90°-Richtung dazu (in Figur 4 also waagerecht statt senkrecht - die Darstellung von Figur 4 ist in bezug auf Figur 3 bereits um 90° gedreht). Wenn also der Querschnitt des Schafts gemäss Figur 4 die obere für den Prothesenquerschnitt gemäss Figur 3 vorbereitete Öffnung passieren soll, muss der Schaft beim Einführen des Bereichs gemäss Figur 3 um 90° gedreht sein, um dann in der (fast) endgültig eingeführten Position seine Normallänge einnehmen zu können. Bei diesem Drehen in die Normalposition gelangt die Schulter in eine Erweiterung der aus Corticalis bestehenden äusseren Knochenstruktur hinein, die als «Trochanter minor» bezeichnet wird. Damit wirkt die Schulter buchstäblich wie ein Zapfen entsprechend einem einseitigen Bajonettverschluss. Die Masse des Schaftes werden dabei den Dimensionen des menschlichen Femurs angepasst.The section according to FIG. 4 goes through the summit area (ridge line) of the elevation designed as shoulder 5. The (additional) shoulder increases the cross-section of the tapered shaft on one side in such a way that the direction of the greatest cross-sectional extension no longer runs here in the plane of curvature, but in a 90 ° direction to it (in FIG. 4, therefore, horizontally instead of vertically) 4 is already rotated by 90 ° with respect to FIG. 3). If the cross-section of the shaft according to FIG. 4 is to pass through the upper opening prepared for the prosthesis cross-section according to FIG. 3, the shaft must be rotated by 90 ° when inserting the area according to FIG to be able to take. During this turning to the normal position, the shoulder enters an extension of the external bone structure consisting of corticalis, which is referred to as the "trochanter minor". The shoulder literally looks like a peg corresponding to a one-sided bayonet catch. The dimensions of the shaft are adapted to the dimensions of the human femur.

Eine entsprechende Gewindebohrung ist auch im Bereich des distalen Schaftendes vorgesehen, was durch die gestrichelte Bohrung 6' angedeutet ist. Diese Bohrung verläuft in der Richtung lateral-medial, da diese Richtung durch das bei der Implantation benutzte Zielgerät leicht zu erreichen ist. Die entsprechenden Fixationsschrauben durchqueren den Femur vollkommen und dienen der zusätzlichen Fixierung des Schaftes.A corresponding threaded hole is also provided in the region of the distal shaft end, which is indicated by the dashed hole 6 '. This hole runs in the lateral-medial direction, since this direction can be easily reached by the aiming device used during the implantation. The corresponding fixation screws cross the femur completely and are used for additional fixation of the shaft.

Die in den Figuren 1 bis 4 wiedergegebene Prothese ist für die Anwendung links gedacht. Sie kann wegen der im Bereich des Trochanter minor ohnehin unsymmetrischen und damit unterschiedlichen Gestaltung für links und rechts durch die in Figur 1 wiedergegebene, in der AP-Ebene verlaufende Krümmung mit grossem Radius den anatomischen Voraussetzungen im linken oder rechten Femur zusätzlich angepasst werden, so dass ein optimaler Sitz gewährleistet ist.The prosthesis shown in FIGS. 1 to 4 is intended for use on the left. Because of the already asymmetrical and therefore different design for the left and right in the area of the trochanter minor, the curvature with a large radius shown in FIG. 1 and running in the AP plane with a large radius can also be adapted to the anatomical requirements in the left or right femur, so that an optimal fit is guaranteed.

Der Bereich maximaler Krafteinleitung bei der erfindungsgemässen Prothese liegt im sich vom distalen Ende zur einseitigen Schulter 5 hin erweiternden Oberflächenbereich. Der sich ergebende Keilwinkel ist dabei so bemessen, dass die radial gerichteten Kräfte begrenzt sind. Der Aufsitz der Prothese und damit die Einleitung von vertikalen Belastungskräften ist über einen so grossen Bereich verteilt, dass Knochenresorption verursachende Mikrobewegungen ausgeschlossen sind. Die Markraumöffnung braucht nicht in aufwendiger Weise einer komplizierten Formgebung unterworfen zu werden, da die erfindungsgemässe Prothese von den vorgefundenen physiologischen Voraussetzungen Gebrauch macht.The area of maximum force application in the prosthesis according to the invention lies in the surface area which widens from the distal end to the unilateral shoulder 5. The resulting wedge angle is dimensioned so that the radially directed forces are limited. The seat of the prosthesis and thus the introduction of vertical loading forces is distributed over such a large area that micro-movements causing bone resorption are excluded. The medullary opening need not be subjected to complicated shaping in a complex manner, since the prosthesis according to the invention makes use of the physiological conditions found.

Die Länge des Prothesenhalses kann - entsprechend den individuellen Voraussetzungen - bei der Herstellung variiert werden.The length of the prosthesis neck can - depending on the individual requirements - be varied during manufacture.

Claims (10)

1. Collarless artificial hip-joint intended for fixing without cement, having a shaft (2) which close to the end will receive the ball (4) of the joint has a change of direction formed by a bend or curve, and the rounded shaft cross-section in which the bend or curve occurs, has a smaller transverse dimension perpendicular to the lateral-medial plane than in that plane, characterised in that on the shaft (2) in the region of the curve or bend is a shoulder-like lump projecting on one side of the lateral-medial plane to provide support in the region of the lesser trochanter, the shoulder-like lump (5) having slopes which are smaller in the longitudinal direction of the shaft than in the transverse direction, the slopes being relative to the shape of the generally oval shaft which tapers uniformly with the bend or curve in the throat region.
2. Artificial hip-joint according to claim 1, characterised in that the shoulder-like lump (5) has a convex ridge line extending in the transverse direction, while the external contour extending in the longitudinal direction of the shaft up to the ridge line on both sides of the lump is of concave shape.
3. Artificial hip-joint according to one of the preceding claims, characterised in that the shaft (2), starting from its end for receiving the ball (4) of the joint, has a taper, so that the contour of the cross-section in the region of the shoulder-like lump (5) is matched to that region of maximum cross-section which is to be formed immediately next to the end which receives or forms the ball of the joint.
4. Artificial hip-joint according to claim 3, characterised in that the direction of the maximum dimension of the cross-sectional contour (Fig. 4) in the region of the shoulder-like lump (5), and the direction of the maximum dimension in the region of the maximum cross-section (Fig. 3), occurring directly next to the end which receives or forms the ball of the joint, seen in the axial direction of the prothesis, form an angle to each other.
5. Artificial hip-joint according to claim 4, characterised in that the directions of maximum dimension form straight lines which do not meet in space and lie substantially perpendicular to each other.
6. Artificial hip-joint according to claim 4 or 5, characterised in that the cross-sectional contour (Fig. 4) in the region of the shoulder-like lump (5) does not extend beyond the surface of the region of maximum cross-section (Fig. 3) which occurs immediately next to the end which receives or forms the ball of the joint, when placed congruently.
7. Artificial hip-joint according to one of the preceding claims, characterised in that the shoulder-like lump (5) has a bore (6) through it which is substantially perpendicular to the main axis and cuts through in the region of the lump parallel to the plane in which the bend or curve runs.
8. Artificial hip-joint according to one of the preceding claims, characterised in that a bore (6') is provided extending transverse to the longitudinal axis of the prothesis and close to the end remote from the connection for the ball of the joint.
9. Artificial hip-joint according to claim 8 characterised in that the bore (6) is threaded.
10. Artificial hip-joint according to one of the preceding claims, characterised in that the shaft (2) has a further, but less pronounced curve about a point forming the centre on the side opposite to the one-sided shoulder-like lump (5).
EP83730051A 1982-05-21 1983-05-24 Hip joint prosthesis without collar Expired EP0095440B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT83730051T ATE21618T1 (en) 1982-05-21 1983-05-24 COLLARLESS HIP PROSTHESIS.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE3219681 1982-05-21
DE3219681 1982-05-21
DE19823237203 DE3237203A1 (en) 1982-05-21 1982-10-05 STEM FOR A COLLARLESS HIP PROSTHESIS
DE3237203 1982-10-05

Publications (2)

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EP0095440A1 EP0095440A1 (en) 1983-11-30
EP0095440B1 true EP0095440B1 (en) 1986-08-27

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EP (1) EP0095440B1 (en)
DE (2) DE3237203A1 (en)

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US4895573A (en) * 1985-07-10 1990-01-23 Harrington Arthritis Research Center Femoral-joint prosthetic device
CH667587A5 (en) * 1985-10-03 1988-10-31 Sulzer Ag SHAFT FOR A FEMURAL HEAD PROSTHESIS.
DE3625520A1 (en) * 1986-03-15 1987-09-17 Mecron Med Prod Gmbh BONE IMPLANT
US4813963A (en) * 1987-08-24 1989-03-21 Zimmer, Inc. Femoral component for a hip prosthesis
DE3731421C2 (en) * 1987-09-18 1997-04-17 Eska Implants Gmbh & Co Femoral hip joint endoprosthesis
US4871369A (en) * 1987-11-23 1989-10-03 Pfizer Hospital Products Group, Inc. Long stem hip implant
JPH0292352A (en) * 1988-09-29 1990-04-03 Aisin Seiki Co Ltd Artificial condyle for hip joint
IT1250907B (en) * 1990-06-22 1995-04-21 Cremascoli G Srl VARIABLE LOCKING PROSTHETIC REVISION STEM
DE4336819C1 (en) * 1993-10-28 1995-03-23 Eska Medical Gmbh & Co Femoral endoprosthesis for a hip joint
FR2725617B1 (en) * 1994-10-12 1997-09-19 Prost Didier FEMALE ROD FOR HIP PROSTHESIS
US5755810A (en) * 1996-11-13 1998-05-26 Cunningham; Robert A. Hip implant prosthesis
US20040158329A1 (en) * 2003-02-10 2004-08-12 Waldemar Link (Gmbh & Co.) Hip joint prosthesis with shaft inserted into femur
EP1623685A1 (en) * 2004-08-06 2006-02-08 WALDEMAR LINK GmbH & Co. KG Hip prosthesis with stem for implantation into the femur
GB2419291A (en) * 2004-10-21 2006-04-26 Biomet Uk Ltd A femoral head prosthesis
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DE3027832A1 (en) * 1980-07-23 1982-03-04 Sigri Elektrographit Gmbh, 8901 Meitingen HIP ENDOPROTHESIS

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US4657551A (en) 1987-04-14
DE3237203A1 (en) 1983-11-24
DE3365618D1 (en) 1986-10-02
EP0095440A1 (en) 1983-11-30

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